Arpizol (Generic Abilify Tablets) - Product Information

Generic Abilify (Arpizol) is an atypical antipsychotic which is used as oral formulations for the treatment of Schizophrenia in adults and adolescents aged 13 to 17 years, treatment of manic or mixed episodes associated with Bipolar I Disorder as monotherapy or adjunctive to lithium or valproate in adults and pediatric patients aged 10 to 17 years and adjunctive treatment of Major Depressive Disorder in adults. Arpizol tablets are manufactured by Sun Pharmaceutical Industries Ltd. in the strengths of 5 mg, 10 mg, 15 mg, 20 mg and 30 mg.

Active Ingredient present in Arpizol Tablets

Uses of Arpizol (Generic Abilify Tablets)

Arpizol (Aripiprazole tablets) is used to treat depressive disorder, schizophrenia, bipolar disorder, and manic depression as following:
• schizophrenia in people age 13 years and older
• bipolar I disorder in people age 10 years and older including manic or mixed episodes that happen with bipolar I disorder
• manic or mixed episodes that happen with bipolar I disorder when used with the medicine lithium or valproate
• long-term treatment of bipolar I disorder
• major depressive disorder in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone
• irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old
• agitation associated with schizophrenia or bipolar disorder

The symptoms of schizophrenia include:
• losing touch with reality (psychosis)
• seeing things or hearing voices that are not there (hallucinations)
• believing things that are not true (delusions)
• being suspicious (paranoia)
• disorganized speech and thinking
• bizarre behavior

The symptoms of bipolar I disorder include:
• extreme mood swings that include feeling depressed and high or irritable mood
• talking too fast and too much
• impulsive behavior
• having more energy and restlessness than usual
• needing less sleep than usual

The symptoms of major depressive disorder (MDD) include:
• feeling of sadness and emptiness
• loss of interest in activities that you once enjoyed and loss of energy
• problems focusing and making decisions
• feeling of worthlessness or guilt
• changes in sleep or eating patterns
• thoughts of death or suicide

Generic Abilify Tablets (Arpizol) - Dosage

The recommended dosage of Aripiprazole tablets (Generic Abilify) for the treatment of various indications is given below.

For Schizophrenia in adults: 10-15 mg/day with an initial dosage of 10-15 mg/day and a maximum of 30 mg/day.For Bipolar mania in adults (monotherapy): the initial dosage is 15 mg/day, the recommended dosage is 15 mg/day and the maximum dosage 30 mg/day. In case Generic Abilify tablets are used as an adjunct to lithium or valproate the initial dose is 10-15 mg/day, the recommended dose is 15 mg/day with the maximum dose being 30 mg/dayTreatment of major depressive disorder in adults as an adjunct to antidepressants: 5-10 mg/day with the starting dose as 2-5 mg/day and the maximum dose being 15 mg/day

Take Arpizol by Sun Pharma (Generic Aripiprazole) exactly as your healthcare provider tells you to. Do not change the dose or stop taking Arpizol (Generic Abilify tablets) by yourself. Arpizol can be taken with or without food.

If you have been prescribed Arpizol by Sun Pharma, take it as follows:
• do not open the blister until ready to take the tablet
• to remove one tablet, open the package and peel back the foil on the blister to expose the tablet
• do not push the tablet through the foil because this could damage the tablet
• immediately upon opening the blister, using dry hands, remove the tablet and place the entire orally disintegrating tablet on the tongue
• tablet disintegration occurs rapidly in saliva
• do not attempt to split the tablet

It is recommended that Aripiprazole be taken without liquid. However, if needed, it can be taken with a glass of water.

Arpizol Tablets (Generic Abilify) - Missed Dose Instructions

If you miss a dose of Arpizol, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of this Arpizol by Sun Pharma at the same time.

Generic Abilify Tablets - Contraindications

Arpizol tablets (Generic Abilify ) are contraindicated for patients that have hypersensitivity to aripiprazole or any inactive ingredient present in Generic Abilify tablets . Hypersensitive reactions have ranged from pruritus/urticaria to anaphylaxis.

Side effects of Arpizol (Generic Abilify Tablets)

The side effects of Arpizol tablets (Generic Abilify) are given below. Serious side effects have been reported with Arpizol (Aripiprazole) including:

Neuroleptic malignant syndrome (NMS)
Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, and changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.

High blood sugar (hyperglycemia)
Increases in blood sugar can happen in some people who take this medicine. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start this medicine and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking generic Abilify:
• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused, or your breath smells fruity
• fainting when rising too quickly from a sitting or lying position

Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition called Tardive dyskinesia. It may not go away, even if you stop taking Arpizol by Sun Pharma (Generic Abilify, Aripiprazole). Tardive dyskinesia may also start after you stop taking Arpizol by Sun Pharma (Generic Abilify, Aripiprazole).

Warnings & Precautions

Before taking Arpizol by Sun Pharma (Generic Abilify, Aripiprazole), tell your healthcare provider if you have or had:

• diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start this medicine and also during therapy
• seizures (convulsions)
• low or high blood pressure
• heart problems or stroke
• pregnancy or plan to become pregnant; it is not known if this medicine will harm your unborn baby
• breast-feeding or plan to breast-feed; it is not known if this medicine will pass into your breast milk

You and your healthcare provider should decide if you will take Aripiprazole or breast-feed. You should not do both.

Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

Generic Abilify (Aripizol by Sun Pharma) and other medicines may affect each other causing possible serious side effects. This medicine may affect the way other medicines work, and other medicines may affect how this medicine works. Your healthcare provider can tell you if it is safe to take this medicine with your other medicines. Do not start or stop any medicines while taking Sun Pharma Arpizol (Generic Abilify) without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how this medicine affects you. This medicine may make you drowsy.

You should:
• not drink alcohol while taking this medicine
• avoid getting over-heated or dehydrated
• not over-exercise
• in hot weather, stay inside in a cool place if possible
• stay out of the sun
• not wear too much or heavy clothing
• drink plenty of water

Arpizol (Generic Abilify Tablets) in Pregnancy and Lactation

Aripiprazole is classified by the US FDA under Category B3. In animal studies aripiprazole demonstrated developmental toxicity, including possible teratogenic effects, in rats and rabbits.
Generic Abilify (Arpizol tablets) should be used during pregnancy only if the expected benefit outweighs the risk and the administered dose and length of treatment should be as low and as short as possible.
Patients should be advised to inform their doctors if they become pregnant or are trying to become pregnant.

Aripiprazole and/or its metabolites have been found in the milk of lactating rats. Arpizol (Generic Aripiprazole) is excreted in breast milk. Patients should be advised not to breast-feed if they are taking Generic Abilify tablets.

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